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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
PMA NumberP040016
Supplement NumberS037
Date Received09/15/2009
Decision Date09/25/2009
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add an alternate trade name for the liberté monorail and over-the-wire coronary stent systems. The device will be marketed under the trade name veriflex bare metal coronary stent and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease with stenotic lesions in native coronary arteries (length <28 mm) with a reference vessel diameter of 2. 75 to 5. 00 mm.